Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64BRIEF SUMMARY GILENYA® (je-LEN-yah) (fingolimod) capsules Read the Medication Guide before you start using GILENYA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your health problem or treatment. What is the most important information I should know about GILENYA? GILENYA may cause serious side effects, including: 1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking GILENYA. GILENYA can cause your heart rate to slow down, especially after you take your first dose. You will have a test to check the electrical activity of your heart (ECG) before you take your first dose of GILENYA. You will be observed by a healthcare professional for at least 6 hours after you take your first dose of GILENYA. After you take your first dose of GILENYA: • Your pulse and blood pressure should be checked every hour. • You should be observed by a healthcare professional to see if you have any serious side effects. If your heart rate slows down too much, you may have symptoms such as: • dizziness • tiredness • feeling like your heart is beating slowly or skipping beats • If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of GILENYA. Symp- toms can happen up to 24 hours after you take your first GILENYA dose. • 6 hours after you take your first dose of GILENYA you will have another ECG. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be observed. • If you have any serious side effects after your first dose of GILENYA, especially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight. You will also be observed for any serious side effects for at least 6 hours after you take your second dose of GILENYA the next day. • If you have certain types of heart problems, or if you are taking certain types of medicines that can affect your heart, you will be observed overnight after you take your first dose of GILENYA. Your slow heart rate will usually return to normal within 1 month after you start taking GILENYA. Call your doctor or go to the nearest hospital emer- gency room right away if you have any symptoms of a slow heart rate. If you miss 1 or more doses of GILENYA you may need to be observed by a healthcare professional when you take your next dose. Call your doctor if you miss a dose of GILENYA. See “How should I take GILENYA?” 2. Infections. GILENYA can increase your risk of serious infections and decrease the way vaccines work in your body to prevent certain diseases, especially the chicken pox vaccine. GILENYA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to nor- mal within 2 months of stopping treatment. Your doctor may do a blood test before you start taking GILENYA. Call your doctor right away if you have any of these symptoms of an infection: • fever • tiredness • body aches • chills • nausea • vomiting • headache accompanied by fever, neck stiffness, sensitivity to light, nau- sea, and/or confusion (these may be symptoms of meningitis) 3. Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems. It is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days, including problems with: • thinking • eyesight • strength • balance • weakness on 1 side of your body • using your arms and legs 4. A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as an MS attack (optic neuritis). You may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 3 to 4 months after you start taking GILENYA. Your doctor should test your vision before you start taking GILENYA and 3 to 4 months after you start taking GILENYA, or any time you notice vision changes during treatment with GILENYA. Your risk of macular edema may be higher if you have diabetes or have had an inflam- mation of your eye called uveitis. Call your doctor right away if you have any of the following: • blurriness or shadows in the center of your vision • a blind spot in the center of your vision • sensitivity to light • unusually colored (tinted) vision What is GILENYA? GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults. GILENYA can decrease the number of MS flare-ups (relapses). GILENYA does not cure MS, but it can help slow down the physical problems that MS causes. It is not known if GILENYA is safe and effective in children under 18 years of age. Who should not take GILENYA? Do not take GILENYA if you: • have had a heart attack, unstable angina, stroke or warning stroke or cer- tain types of heart failure in the last 6 months • have certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom a heart finding called prolonged QT is seen on ECG before starting GILENYA • are taking certain medicines that change your heart rhythm • are allergic (hypersensitive) to fingolimod or any of the other ingredients of GILENYA listed at the end of this medication guide. Allergic reactions, which could include symptoms of rash or itchy hives, swelling of lips, tongue or face, are more likely to occur on the day you start GILENYA treatment but may occur later. If you think you may be allergic, ask your doctor for advice. If any of the above situations apply to you, tell your doctor. What should I tell my doctor before taking GILENYA? Before you take GILENYA, tell your doctor about all your medical condi- tions, including if you had or now have: • an irregular or abnormal heartbeat (arrhythmia) • a history of stroke or warning stroke • heart problems, including heart attack or angina • a history of repeated fainting (syncope) • a fever or infection, or you are unable to fight infections due to a disease or taking medicines that lower your immune system. Tell your doctor if you have had chicken pox or have received the vaccine for chicken pox. Your doctor may do a blood test for chicken pox virus. You may need to get the full course of the vaccine for chicken pox and then wait 1 month before you start taking GILENYA. • eye problems, especially an inflammation of the eye called uveitis. • diabetes • breathing problems, including during your sleep • liver problems • high blood pressure • a type of skin cancer called basal cell carcinoma (BCC). • Are pregnant or plan to become pregnant. GILENYA may harm your unborn baby. Talk to your doctor if you are pregnant or are planning to become pregnant. • Tell your doctor right away if you become pregnant while taking GILENYA or if you become pregnant within 2 months after you stop taking GILENYA. • If you are a female who can become pregnant, you should use effec- tive birth control during your treatment with GILENYA and for at least 2 months after you stop taking GILENYA. Pregnancy Registry: There is a registry for women who become preg- nant during treatment with GILENYA. If you become pregnant while taking GILENYA, talk to your doctor about registering with the GILENYA Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by sending an email to gpr@quintiles.com, or go to www.gilenyapregnancyregistry.com. • Are breastfeeding or plan to breastfeed. It is not known if GILENYA passes into your breast milk. You and your doctor should decide if you will take GILENYA or breastfeed. You should not do both. Tell your doctor about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines that affect your immune system, including corticosteroids, or have taken them in the past. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine. Using GILENYA and other medicines together may affect each other causing serious side effects.